Cefdinir

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Cefdinir Prescribing Information

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension and other antibacterial drugs, cefdinir for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Cefdinir for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

(see

INDICATIONS AND USAGE

Cefdinir for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

Adults and Adolescents:

Community-Acquired Pneumonia:

Caused by Haemophilus influenzae

(including β-lactamase producing strains),

Haemophilus parainfluenzae

(including β-lactamase producing strains),

Streptococcus pneumoniae

(penicillin-susceptible strains only), and

Moraxella catarrhalis

(including β-lactamase producing strains) (see

CLINICAL STUDIES

Acute Exacerbations of Chronic Bronchitis:

Caused by

Haemophilus influenzae

(including β-lactamase producing strains),

Haemophilus parainfluenzae

(including β-lactamase producing strains),

Streptococcus pneumoniae

(penicillin-susceptible strains only), and

Moraxella catarrhalis

(including β-lactamase producing strains).

Acute Maxillary Sinusitis:

Caused by

Haemophilus influenzae

(including β-lactamase producing strains),

Streptococcus pneumoniae

(penicillin-susceptible strains only), and

Moraxella catarrhalis

(including β-lactamase producing strains).

NOTE

: For information on use in pediatric patients, see

Pediatric Use

and

DOSAGE AND ADMINISTRATION.

Pharyngitis/Tonsillitis:

Caused by

Streptococcus pyogenes

(see

CLINICAL STUDIES

NOTE

: Cefdinir is effective in the eradication of

S. pyogenes

from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following

S. pyogenes

pharyngitis/tonsillitis.

Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.

Uncomplicated Skin and Skin Structure Infections:

Caused by

Staphylococcus aureus

(including β-lactamase producing strains) and

Streptococcus pyogenes

Pediatric Patients:

Acute Bacterial Otitis Media:

Caused

Haemophilus influenzae

(including β-lactamase producing strains),

Streptococcus pneumoniae

(penicillin-susceptible strains only), and

Moraxella catarrhalis

(including β-lactamase producing strains).

Pharyngitis/Tonsillitis:

Caused by

Streptococcus pyogenes

(see

CLINICAL STUDIES

NOTE

: Cefdinir is effective in the eradication of

S. pyogenes

from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following

S. pyogenes

pharyngitis/tonsillitis.

Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.

Uncomplicated Skin and Skin Structure Infections:

Caused by

Staphylococcus aureus

(including β-lactamase producing strains) and

Streptococcus pyogenes

for Indicated Pathogens)

The recommended dosage and duration of treatment for infections in pediatric patients are described in the following chart; the total daily dose for all infections is 14 mg/kg, up to a maximum dose of 600 mg per day. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in skin infections; therefore, cefdinir for oral suspension should be administered twice daily in this infection. Cefdinir for oral suspension may be administered without regard to meals.

Pediatric Patients (Age 6 Months Through 12 Years)
Header$Type of Infection	Dosage	Duration
Acute Bacterial Otitis Media	7 mg/kg q12h or	5 to 10 days
	14 mg/kg q24h	10 days
Acute Maxillary Sinusitis	7 mg/kg q12h or	10 days
	14 mg/kg q24h	10 days
Pharyngitis/Tonsillitis	7 mg/kg q12h or	5 to 10 days
	14 mg/kg q24h	10 days
Uncomplicated Skin and Skin Structure Infections	7 mg/kg q12h	10 days

CEFDINIR FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART
^a Pediatric patients who weight ≥43 kg should receive the maximum daily dose of 600 mg.
Header$Weight	125 mg/5 mL	250 mg/5 mL
9 kg/20 lbs	2.5 mL q12h or 5 mL q24h	Use 125 mg/5 mL product
18 kg/40 lbs	5 mL q12h or 10 mL q24h	2.5 mL q12h or 5 mL q24h
27 kg/60 lbs	7.5 mL q12h or 15 mL q24h	3.75 mL q12h or 7.5 mL q24h
36 kg/80 lbs	10 mL q12h or 20 mL q24h	5 mL q12h or 10 mL q24h
≥43 kg^a/95 lbs	12 mL q12h or 24 mL q24h	6 mL q12h or 12 mL q24h

Cefdinir for oral suspension contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α,7β(Z)]]-7-[[(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The molecular formula is C₁₄H₁₃N₅O₅S₂ and the molecular weight is 395.42. Cefdinir has the structural formula shown below:

Cefdinir for oral suspension, after reconstitution, contains 125 mg cefdinir per 5 mL or 250 mg cefdinir per 5 mL and the following inactive ingredients: anhydrous citric acid; colloidal silicon dioxide; guar gum; anhydrous sodium citrate; sodium benzoate; strawberry flavour; sucrose; and xanthan gum.

Oral Bioavailability:

Maximal plasma cefdinir concentrations occur 2 to 4 hours postdose following capsule or suspension administration. Plasma cefdinir concentrations increase with dose, but the increases are less than dose-proportional from 300 mg (7 mg/kg) to 600 mg (14 mg/kg). Following administration of suspension to healthy adults, cefdinir bioavailability is 120% relative to capsules. Estimated bioavailability of cefdinir capsules is 21% following administration of a 300 mg capsule dose, and 16% following administration of a 600 mg capsule dose. Estimated absolute bioavailability of cefdinir suspension is 25%. Cefdinir oral suspension of 250 mg/5 mL strength was shown to be bioequivalent to the 125 mg/5 mL strength in healthy adults under fasting conditions.

Effect of Food:

The C_max and AUC of cefdinir from the capsules are reduced by 16% and 10%, respectively, when given with a high-fat meal. In adults given the 250 mg/5 mL oral suspension with a high-fat meal, the C_maxand AUC of cefdinir are reduced by 44% and 33%, respectively. The magnitude of these reductions is not likely to be clinically significant because the safety and efficacy studies of oral suspension in pediatric patients were conducted without regard to food intake. Therefore, cefdinir may be taken without regard to food.

Cefdinir Suspension

Cefdinir plasma concentrations and pharmacokinetic parameter values following administration of single 7 and 14 mg/kg oral doses of cefdinir to pediatric subjects (age 6 months-12 years) are presented in the following table:

Mean (±SD) Plasma Cefdinir Pharmacokinetic Parameter Values Following Administration of Suspension to Pediatric Subjects
Dose	Cmax ( mcg / mL )	tmax ( hr )	AUC ( mcg . hr / mL )
7 mg/kg	2.30(0.65)	2.2(0.6)	8.31(2.50)
14 mg/kg	3.86(0.62)	1.8(0.4)	13.4(2.64)

Multiple Dosing:

Cefdinir does not accumulate in plasma following once- or twice-daily administration to subjects with normal renal function.

In a controlled, double-blind study in adults and adolescents conducted in the US, cefdinir BID was compared with cefaclor 500 mg TID. Using strict evaluability and microbiologic/clinical response criteria 6 to 14 days posttherapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained:

US Community-Acquired Pneumonia Study Cefdinir vs Cefaclor
	Cefdinir BID	Cefaclor TID	Outcome
Clinical Cure Rates	150/187 (80%)	147/186 (79%)	Cefdinir equivalent to control
Eradication Rates
Overall	177/195 (91%)	184/200 (92%)	Cefdinir equivalent to control
S . pneumoniae	31/31 (100%)	35/35 (100%)
H . influenzae	55/65 (85%)	60/72 (83%)
M . catarrhalis	10/10 (100%)	11/11 (100%)
H . parainfluenzae	81/89 (91%)	78/82 (95%)

In a second controlled, investigator-blind study in adults and adolescents conducted primarily in Europe, cefdinir BID was compared with amoxicillin/clavulanate 500/125 mg TID. Using strict evaluability and clinical response criteria 6 to 14 days posttherapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained:

European Community-Acquired Pneumonia Study Cefdinir vs Amoxicillin/Clavulanate
	Cefdinir BID	Amoxicillin / Clavulanate TID	Outcome
Clinical Cure Rates	83/104 (80%)	86/97 (89%)	Cefdinir not equivalent to control
Eradication Rates
Overall	85/96 (89%)	84/90 (93%)	Cefdinir equivalent to control
S . pneumoniae	42/44 (95%)	43/44 (98%)
H . influenzae	26/35 (74%)	21/26 (81%)
M . catarrhalis	6/6 (100%)	8/8 (100%)
H . parainfluenzae	11/11 (100%)	12/12 (100%)

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